Balloon angiopLasty for Intracranial Atherosclerotic Minor Stroke/TIA

Balloon angiopLasty for Intracranial Atherosclerotic Minor Stroke/TIA: a Prospective, Multi-center, Register Study

The objective of this study was to evaluate the safety and efficacy of early submaximal balloon angioplasty combined with medical therapy vs medical therapy alone for minor stroke/transient ischemic attack with intracranial atherosclerosis etiology.

Study Overview

• Status: Recruiting
• Conditions: Ischemic Stroke
• Intervention / Treatment: Procedure: Submaximal balloon angioplasty

Detailed Description

In this study, 416 patients with minor strokes or transient ischemic attacks due to symptomatic intracranial atherosclerotic stenosis within one week of the onset of last ischemic symptoms from 20 centers in China were enrolled. The observation group received early submaximal balloon angioplasty, while the control group received only medical therapy. Two groups will be followed up for 1 year to evaluate the safety and efficacy of early submaximal balloon angioplasty combined with medical therapy vs medical therapy alone for minor stroke / transient ischemic attack with intracranial atherosclerosis etiology.

• Study Type: Observational
• Enrollment (Estimated): 416

Contacts and Locations

• Study Contact: Name: Shouchun Wang, MD, PhD; Phone Number: 0086-13596060906; Email: WSC@jlu.edu.cn
• Study Contact Backup: Name: Huisheng Chen, MD, PhD; Phone Number: 0086-13352452086; Email: chszh@aliyun.com

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130000
      • Recruiting
      • the first hospital of Jilin University
      • Contact: Shouchun MD Wang, MD,PhD; Phone Number: 0086 13596060906; Email: WSC@jlu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients with minor stroke/transient ischemic attack.

Description

Inclusion Criteria:

1. age range of 30-80 years;
2. symptomatic ICAS (C4-C7 segments of ICA, M1 segment of the MCA, V4 segment of the VA, and BA) with 70%-99% stenosis confirmed by DSA;
3. minor stroke (NIHSS score ≤5) within 1 week of onset or from symptom exacerbation (NIHSS score increased by ≥2 points) or intermediate- to high-risk TIA, defined as ABCD2 score ≥4 within 1 week of the last symptom episode;
4. diameter of the culprit artery ranging from 2.0 to 4.5mm, and the length of the stenosis≤14mm;
5. mRS ≤ 2 before endovascular treatment；
6. no large ischemic region found on CT or MRI (ASPECTS≥ 6 or pc-ASPECTS ≥8)；
7. written informed consent obtained from the patient or legally responsible person.

Exclusion Criteria:

1. allergy to contrast media;
2. non-atherosclerotic disease-related stenosis, such as arterial dissection, Moya-Moya disease, and arteritis;
3. penetrating branch lesion ipsilateral to the target lesion (infarction caused by penetrating branch occlusion is defined as stenosis of the MCA or BA, but only with simple basal ganglia or brainstem/thalamic infarction);
4. presence of severe stenosis of the extracranial segment on the side of the target lesion;
5. previous endovascular treatment of the ipsilateral vessel;
6. presence of intracranial aneurysms, tumors, and vascular malformations;
7. any form of ipsilateral intracranial hemorrhage within 3 months and contralateral intracranial hemorrhage within 2 weeks;
8. presence of atrial fibrillation, severe heart dysfunction, liver or kidney dysfunction; patients with tumors and serious diseases whose expected survival time is ≤ 1 year;
9. hemoglobin ≤ 100g/L, platelet count ≤ 100×10^9/L, INR> 1.5 (irreversible), coagulopathy or irremediable bleeding factors;
10. uncontrollable hypertension: systolic blood pressure >185 mmHg and/or diastolic blood pressure >110 mmHg;
11. poor glycemic control (random blood glucose > 22.2 mmol/L);
12. history of major surgery within 30 days prior to enrollment or surgery plan within 90 days after enrollment;
13. pregnancy or lactation;
14. other conditions that the researchers think make the patient unsuitable for the study.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observation group; The observation group received early submaximal balloon angioplasty and medical therapy.	Procedure: Submaximal balloon angioplasty; The goal of submaximal balloon angioplasty is to use the balloon to improve the stenosis of the criminal artery by more than 20%.
Control group; The control group received only medical therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke or death within 30 days or ischemic stroke in the culprit artery territory from 30 days to 1 year	Stroke or death within 30 days or ischemic stroke in the culprit artery territory from 30 days to 1 year	30 days, 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke or death within 30 days after enrollment	Stroke or death within 30 days after enrollment	30 days
Ischemic stroke in the territory of criminal artery from 30 days to 1 year after enrollment	Ischemic stroke in the territory of criminal artery from 30 days to 1 year after enrollment	1 year
Restenosis rate of criminal artery within 1 year after enrollment	Restenosis rate of criminal artery within 1 year after enrollment	1 year
Evaluation of neurological function improvement within 90 days of enrollment	Evaluation of neurological function improvement within 90 days of enrollment	90 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intracranial hemorrhage within 30 days of enrollment	Intracranial hemorrhage within 30 days of enrollment	30 days
Complications associated with endovascular therapy	Complications associated with endovascular therapy	24 hours, discharge, 30 days, 90 days, and 1 year after enrollment

Collaborators and Investigators

• Sponsor: Shouchun Wang, MD, PhD
• Collaborators: The General Hospital of Northern Theater Command

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: August 21, 2023
• First Submitted That Met QC Criteria: August 25, 2023
• First Posted (Actual): August 28, 2023

Study Record Updates

• Last Update Posted (Actual): January 3, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: BLAST

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No